NCT01193790

Brief Summary

The investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

September 20, 2010

Status Verified

September 1, 2010

Enrollment Period

1.9 years

First QC Date

September 1, 2010

Last Update Submit

September 17, 2010

Conditions

Tonsillitis

Keywords

chronic tonsillitisradio-frequency coblationradio-frequency coblation in chronic tonsillitis treatment

Outcome Measures

Primary Outcomes (1)

  • RF coblation may be promising in treating chronic tonsillitis.

    2 years

Secondary Outcomes (1)

  • RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure.

    2 years

Study Arms (1)

Coblation

EXPERIMENTAL
Procedure: Coblation channeling

Interventions

Coblation channelingPROCEDURE

The combination of the energy and the fluid creates a "plasma" field containing highly ionized particles (coblation). The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and subsequent damage to the surrounding tissue. Treatment of the tonsillar crypts and tissue by coblation may decrease antigen and immune system interaction and inflammation.

Coblation

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • suffering from at least 4 episodes of tonsillitis in past year.
  • suffering from recurrent or chronic sore throat.
  • suffering from irregular tonsils with crypts, slight redness or enlargement.

You may not qualify if:

  • suffering from mouth ulcers or other oral מחלת ריריות
  • allergic to the type of medication included in the study.
  • suffering from gastrointestinal (GI) reflux or chronic הפרשה הוסטנזלית
  • contraindication to medical or surgical treatment.
  • suffering from peritonsillar abscess.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe MC,

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Last Updated

September 20, 2010

Record last verified: 2010-09

Locations

IL(1)